NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Light and the Effect on Metabolic Syndrome and Alzheimer's Disease

CompletedNA

Sponsor: Icahn School of Medicine at Mount Sinai

Conditions: Alzheimer Disease, Diabetes Mellitus, Type 2

Interventions: Tailored Lighting Intervention

Countries: United States

This study's main hypothesis is that a delivering a tailored lighting intervention (TLI) will provide a successful means for promoting circadian entrainment and treating metabolic disease and inflammation in patients with mild cognitive impairment (MCI) and Alzheimer's disease (AD) and Alzheimer's disease and related dementias (ADRD). As such, the proposed studies have the potential to provide important insights into the link between AD/ADRD and type 2 diabetes (T2DM) by identifying the disruption of circadian rhythms as a key component in the metabolic impairment. Preliminary data from ongoing studies demonstrates a beneficial effect of light treatment on sleep and depression. If positive results are observed, the potential also exists to transform the manner in which homes, assisted living facilities, and nursing homes are lighted by delivering a simple, practical, non-pharmacological intervention to promote entrainment, improve sleep, and reduce metabolic disease in AD and mild AD MCI patients. This randomized, placebo-controlled, crossover study involving 60 AD/ADRD patients who live in controlled environments (i.e., assisted living facilities and nursing homes), will investigate whether 8 weeks of exposure to a TLI designed to increase circadian entrainment improves sleep, mood, inflammatory markers, and metabolic control, compared to a control, circadian-inactive light.

Eligibility overview

Sex: ALL

Age: 55 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Diagnosis of mild to moderate Alzheimer's disease or related dementia,
* sleep disturbance as determined by a score ≥ 5 on the PSQI

Exclusion Criteria:

* insulin-dependent diabetes,
* urinary incontinence
* obstructing cataracts
* macular degeneration
* blindness
* severe sleep apnea or
* restless leg syndrome (RLS)

Locations (3)

New Brunswick, New Jersey, United States
Albany, New York, United States
New York, New York, United States